Study evaluated the utility of Banyan BTI™, a diagnostic blood test,
to rule out the need for a CT scan in patients with a suspected mild
TBI, or concussion, presenting to the emergency department within 12
hours of head injury.

July 24, 2018 06:30 PM Eastern Daylight Time

SAN DIEGO--(BUSINESS WIRE)--Banyan
Biomarkers, Inc., a pioneer in developing biomarkers for traumatic
brain injury (TBI), today announced the publication of the results for
the ALERT-TBI study, an international, multicenter clinical trial
utilizing the Banyan Brain Trauma Indicator® (Banyan BTI™).
The Banyan BTI is a diagnostic blood test used to rule out the need for
a head CT scan in patients 18 years of age and older with a suspected
TBI. The results, published in The Lancet Neurology, support the
clinical role of the biomarker test for ruling out the need for a head
CT scan among emergency department TBI patients who would normally
receive a head CT scan.

The ALERT-TBI study enrolled patients at 22 independent clinical sites
in the United States and Europe and compared the Banyan BTI test's
results to head CT scans of patients presenting to emergency departments
with suspected head injury. Analysis of 1,959 patients presenting with
an initial Glasgow Coma Scale of 9-15 from the study showed that the
Banyan BTI achieved high sensitivity (97.6%) and high negative
predictive value (NPV) (99.6%) for ruling out the need for a head CT
scan in these patients.

Banyan BTI identifies two brain-specific protein biomarkers Ubiquitin
Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic
Protein (GFAP) that are detected in the blood soon after a brain injury.
In February, the U.S. Food and Drug Administration (FDA) granted
marketing authorization to Banyan Biomarkers for the commercialization
of Banyan BTI to aid in the evaluation of patients with a suspected mild
TBI or concussion. There is another biomarker, S100B, that has limited
adoption in Europe but is not approved for use in the United States.

“This blood test meets an important public health need to reduce the
number of unnecessary CT scans particularly among those with mild
TBI—also called concussion—who make up over 85% of all TBIs. In
emergency medicine, CT scans are often used in evaluating these
patients, even though fewer than 10 percent of scans reveal an
abnormality,” said Jeff Bazarian, MD, MPH, principal investigator of the
study, one of the lead authors on the publication, and professor of
Emergency Medicine and Neurology at The University of Rochester School
of Medicine. “This extensive clinical study shows that these two
blood-based brain biomarkers can predict the absence of intracranial
injury and reduce unnecessary head CT scanning, thereby reducing
radiation exposure and healthcare costs while improving patient care and
emergency department efficiency.”

“This large, prospective, multicenter trial validated the ability of the
Banyan BTI to rule out the need for head CT scan in patients with a
suspected TBI within 12 hours after injury. The FDA reviewed and
authorized for marketing the test in fewer than six months as part of
its Breakthrough Devices Program,” said Henry L. Nordhoff, Chairman and
CEO of Banyan Biomarkers. “We are working closely with our commercial
partners to make the test available in hospitals and emergency
departments.”

The company is also engaged in additional TBI studies to evaluate the
biomarkers in sports concussions, in adolescents, and for monitoring
recovery from brain injury.

The clinical study was supported by the U.S. Army Medical Research
and Materiel Command under Contract No. W81XWH-10-C-0251. Any views,
opinions, conclusions, and/or findings contained in this press release
are those of Banyan Biomarkers, Inc. and should not be construed as an
official Department of the Army position, policy, or decision, unless so
designated by other documentation.

About Traumatic Brain Injury (TBI)

Falls, automobile accidents, sports-related injuries, assaults, and, in
the military, improvised explosive devices (IEDs) and combat wounds are
common causes of TBI. The U.S. Center for Disease Control estimates
there are more than 2.5 million emergency room visits in the United
States because of head injuries and TBI is an economic burden of more
than $76 billion annually on the healthcare system.1
Traumatic brain injury is the leading cause of disability and the number
one cause of death for young adults.2

Banyan Biomarkers, Inc. has developed the first blood test, Banyan BTI™,
that can be used by physicians to objectively aid in the evaluation of
patients with suspected traumatic brain injury (TBI), also known as
concussions. Banyan BTI consists of two test kits (Banyan UCH-L1®
Kit and Banyan GFAP® Kit) that measure two specific protein
biomarkers that rapidly appear in the blood after a brain injury. To
learn more about the Company and Banyan BTI, visit www.banyanbio.com.